Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.
Role Overview
Reporting to the Senior Director for Global HEOR and Evidence Generation, the Associate Director will be an integral member of the Medical and Patient Affairs (MPA) team who will support regulatory and commercial evidence generation needs. This individual will support the HEOR and Evidence Generation Strategy for ETX101, the first gene therapy for Dravet Syndrome, as well as the Encoded pipeline, as needed.
ETX101 and ETX301 are single-administration, potentially transformative intervention. As such, this individual should understand the fundamentals for global evidence requirements for regulatory and health authority submissions for HEOR research in a gene therapy context. They will be responsible for supporting the execution of a sophisticated, long-term value evidence package for global stakeholders, and for designing and implementing effective solutions that optimize value and patient access discussions. This is a high-impact role for an individual who thrives on translating vision into execution within a fast-evolving and innovative environment.
Primary Responsibilities
Strategic Alignment & Patient Access
- HEOR & Patient Access Strategy: Shape, align, and support the execution of global HEOR strategies to support product approval, clinical differentiation, and optimal patient access for Encoded assets.
- Global HTA & Payer Alignment: Maintain a deep understanding of global Health Technology Assessment (HTA) requirements to shape evidence generation, demonstrating strong familiarity with major ex-US HTA bodies, as well as the evolving US payer and value assessment landscape.
- Launch Readiness & Commercialization: Execute HEOR-related commercial strategies to support successful asset launches.
- Cross-Functional Collaboration: Serve as a subject matter expert, partnering with Clinical, Regulatory, Commercial, Medical Affairs, and Patient Advocacy to integrate HEOR into the broader global evidence generation strategy.
- Regulatory Alignment: Maintain a comprehensive working knowledge of global regulatory guidelines, internal compliance policies, and Medical-Legal-Regulatory (MLR) review processes to ensure all activities meet the highest ethical standards.
HEOR Tactical Execution & Scientific Quality
- Evidence Generation Portfolio: Lead global HEOR research initiatives, which may include literature reviews, natural history, disease burden, observational research and Clinical Outcomes Assessments (COA/PRO), as well as health economic and epidemiological modeling.
- Evidence Landscaping & Synthesis: Lead systematic landscape assessments, and data gap analyses to inform asset strategy, contextualize disease burden, and identify optimal data sources.
- Project & Vendor Management: Oversee planning, budgeting, execution, and timely dissemination of research findings, managing external vendors and scientific partnerships to align objectives and timelines.
- Scientific Rigor & Governance: Maintain excellent scientific rigor and quality across proposals, protocols, and statistical analysis plans, ensuring robust defense of research in internal and external forums.
Scientific Proficiency & Organizational Leadership
- Subject-Matter Expertise: Demonstrate a proven track record of scientific expertise in at least two core HEOR disciplines (e.g., epidemiology, economic modeling, observational research, or mixed-methods/qualitative-quantitative research).
- Internal Capability Building: Develop and implement best practices, governance frameworks, and educational resources, as needed to scale HEOR standards and capabilities across Encoded.
- Value-Centric Culture: Champion the HEOR and payer perspective internally, contributing to corporate initiatives that embed a value-driven mindset across the organization.
Qualifications
Education & Experience
- Advanced Degree Required: Master’s degree (MS, MPH), MD, PharmD, or PhD in Health Economics and Outcomes Research (HEOR), Epidemiology, Biostatistics, Public Health, Psychology, or a related quantitative/scientific discipline.
- Industry Experience: Minimum of 5 years of relevant pharmaceutical industry or specialized consulting experience.
- Core Research Expertise: Proven track record in study design and execution across observational research, Patient Experience Data (PED), Clinical Outcome Assessments (COA/PRO) development, psychometric validation, and health economic modeling.
Technical & Strategic Capabilities
- End-to-End Evidence Generation: Demonstrated ability to lead HEOR research from initial conceptualization and protocol development through to peer-reviewed scientific publication and defense before global health authorities.
- Global HTA & Regulatory Submissions: Direct experience preparing and delivering HEOR components for global regulatory dossiers and Health Technology Assessment (HTA) submissions.
- Matrix & Global Project Management: Excellent project management skills with a history of successfully managing multiple complex projects, budgets, and external vendor partnerships in rapidly changing global matrix environments.
- Compliance & Clinical Frameworks: Strong working knowledge of pharmaceutical compliance frameworks, legal/regulatory review processes, and clinical trial designs.
Leadership & Communication
- Strategic Influence: Exceptional interpersonal and communication skills, with a proven ability to leverage deep scientific expertise to influence, collaborate, and align diverse internal and external stakeholders.
- Agility & Advisory: Ability to rapidly synthesize complex data to answer strategic business questions and establish cross-functional HEOR best practices.
- Travel Flexibility: Willingness to travel domestically and internationally as needed to support research initiatives and global business priorities.
Preferred Skills & Experience
- Advanced Scientific Degree: PhD in HEOR or related scientific discipline
- Therapeutic Expertise: Direct experience supporting programs in rare genetic disorders, neurology (specifically, epilepsy, neurodevelopmental disorders or pain) or advanced therapeutics (e.g. gene and cell therapies)
- Commercialization & Launch: Hands-on experience supporting assets through late-stage development, pre-launch commercialization and global launch execution
- Comprehensive benefits package, including competitive employer premium contributions
- Meaningful stock option grants
- PTO, sick time and holiday pay
- Generous Parental Leave program
- Pre-tax medical and dependent care programs
- STD, LTD, Life and AD&D
- Professional development opportunities
- Team-building events
- Fully stocked micro - kitchen
- Fitness center at South San Francisco location
Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.
If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.